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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dialyzer, Capillary, Hollow Fiber
510(k) Number K892374
Device Name NEW AM-SERIES DIALYZERS
Applicant
Asahi Medical Co., Ltd.
Intl. Sq.
1825 Eye St., NW Suite 400
Washington,  DC  20006
Applicant Contact RICHARD T NEY
Correspondent
Asahi Medical Co., Ltd.
Intl. Sq.
1825 Eye St., NW Suite 400
Washington,  DC  20006
Correspondent Contact RICHARD T NEY
Regulation Number876.5820
Classification Product Code
FJI  
Date Received03/31/1989
Decision Date 05/18/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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